The following data is part of a premarket notification filed by Computer Motion, Inc. with the FDA for Bipolar Grasper And Bipolar Scissors For The Zeus Microwrist Surgical System.
| Device ID | K030578 |
| 510k Number | K030578 |
| Device Name: | BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM |
| Classification | System, Surgical, Computer Controlled Instrument |
| Applicant | COMPUTER MOTION, INC. 130-B CREMONA DR. Goleta, CA 93117 |
| Contact | Cathy Stupak |
| Correspondent | Cathy Stupak COMPUTER MOTION, INC. 130-B CREMONA DR. Goleta, CA 93117 |
| Product Code | NAY |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-02-24 |
| Decision Date | 2003-06-24 |
| Summary: | summary |